Senior Validation Engineer II – Med Device Quality

integralife; Braintree (MA); On-site; USD 94,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Job summary

Integra LifeSciences in Massachusetts seeks a Senior Validation Specialist to lead qualification and validation activities for NPI, transfers, and related projects. You will develop and review protocols, support risk analysis, and ensure compliance with cGMP, QSR, ISO and related standards.

The ideal candidate has a strong engineering or science background, 8+ years in validation/QA for medical devices or pharma, and proven project management and technical writing skills.

Qualifications

• 8+ years in validation or quality assurance for medical devices or pharmaceutical environments.
• Excellent organizational and communication skills.
• Results-oriented with a strong focus on quality principles.
• Experience conducting validation studies and managing projects independently.
• Ability to track milestones and manage validation projects.

Responsibilities

• Specialized knowledge in validation areas and contribution to QA processes.
• Prepare, review, and route qualification/validation protocols and summaries.
• Lead risk management activities including PFMEA generation.
• Coordinate scheduling, resources, and documentation for validation assignments.
• Serve as validation representative on cross-functional teams for transfers and NPI.
• Support and address comments on validation and engineering documents.

Skills

Validation expertise

Project management

Regulatory compliance

Technical writing

Education

Bachelor's degree in Engineering or Science

Tools

PFMEA

Job description

Integra LifeSciences in Massachusetts seeks a Senior Validation Specialist to lead qualification and validation activities for NPI, transfers, and related projects. You will develop and review protocols, support risk analysis, and ensure compliance with cGMP, QSR, ISO and related standards.

The ideal candidate has a strong engineering or science background, 8+ years in validation/QA for medical devices or pharma, and proven project management and technical writing skills.